FDA Approval of Lymphir Is ‘Thrilling’ for Rare Lymphoma

“As a physician who treats patients with cutaneous lymphoma, I was thrilled to hear that the FDA approved Lymphir, which is a highly active drug, and a new option for patients with persistent or relapsed disease,” said Dr. Francine M. Foss said.

The recent approval by the Food and Drug Administration (FDA) of Lymphir (denileukin diftitox-cxdl) for the treatment of relapsed/refractory cutaneous T-cell lymphoma (r/r CTCL) was “thrilling,” as one expert explained to CURE®.

“As a physician who treats patients with cutaneous lymphoma, I was thrilled to hear that the FDA approved Lymphir, which is a highly active drug, and a new option for patients with persistent or relapsed disease,” said Dr. Francine M. Foss, director of the multidisciplinary T cell lymphoma program at Yale Cancer Center and Smilow Cancer Hospital, via email.

Foss was among the researchers on the phase 3 Study 302, findings of which supported the FDA’s approval of Lymphir as the first novel targeted systemic therapy approved by the agency for r/r CTCL since 2018.

Study 302, according to a news release from Lymphir’s manufacturer Citius Pharmaceuticals, Inc., displayed a 36% objective response rate (the percentage of patients who responded partially or completely to treatment) and 8.7% complete response rate with 84% of patients experiencing a reduction in skin disease.

The benefit of this drug, according to Foss, is that it is highly active and with an early onset of action; most of the patients who responded experienced their response in the first two cycles of therapy, while a subset of patients have been able to stay on the drug for up to eight months.

CTCL, according to the National Cancer Institute, is a type of cancer that begins in the T cells, a type of white blood cell and part of the body’s immune system, and affects the skin, with most cutaneous T-cell lymphomas marked by a rash that can thicken or form tumors on the skin, or by skin redness and swollen lymph nodes.

In Study 302, the median time to response was 1.41 months, with approximately 70% experiencing results after one to two cycles of treatment and a duration of response of at least six months among 52% of patients, according to the news release.

Among skin-evaluable patients, 84.4% had a decrease in skin tumor burden, and 12.5% experienced a complete clearing of skin disease, while 31.7% of patients had clinically significant improvement in pruritis, or itchiness.

“Lymphir is a targeted therapy,” Foss said. “It specifically binds to and kills cells that express the interleukin-2 receptor. This includes lymphoma cells such as those in CTCL, but also — and importantly — it also includes regulatory T cells that might be inhibiting the body’s natural response to cancer. Because this drug is targeted, it is not associated with many of the side effects that are seen with conventional chemotherapy drugs.”

Regarding side effects, Foss noted that Lymphir has a favorable toxicity profile compared to other treatments, and that it does not cause nausea, hair, loss, diarrhea, mouth sores or other side effects associated with chemotherapy.

“Lymphir is a highly active drug which addresses an unmet medical need for patients with cutaneous lymphoma,” Foss said. “Future studies are planned to combine it with other active agents to try to enhance its activity. The drug is also being explored in other types of lymphoma.”

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